ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number ACU0T0 |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that following an intraocular lens (iol) implant procedure, mark/scratch on the lens near to the edge.It was near to the edge so would not able to explant.Lens still implanted in patients eye.Additional information was requested, but no further information is available.
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Manufacturer Narrative
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Additional information provided in h.3., h.6., and h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the ifu.A non-qualified viscoelastic was used in the device.The ifu instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.The account indicated the product was not available to evaluate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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